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I have also found that, in recent years, my options for good, quality steaks have increased significantly, as food processors and restaurant chains look for ways to distinguish themselves and their products. Industry has moved toward more value-added products, such as mechanically tenderized steaks, using needles to soften the meat and even to inject marinade. Indeed, I think it would be safe to say that the vast majority of steaks now consumed in restaurants are mechanically tenderized.

The use of such technologies, however, creates additional food safety challenges not present in non-tenderized products. This is because, to the extent there is any possible pathogenic contamination present on the exterior of a steak, the process of mechanical tenderization can push that contamination deep into the product, where it becomes more difficult to destroy through cooking.

With that backdrop, the U.S. Department of Agriculture is now becoming more involved in helping educate end-users on the risks associated with mechanically tenderized products. In particular, USDA has published new proposed rules requiring meat processors to properly label any mechanically tenderized meat products they sell. These new rules will likely have two effects: (1) they may make mechanically-tenderized rare or medium rare steaks nearly impossible to sell; and (2) they may drive the vast majority of these products out of the food service market.

Here’s why. In addition to requiring processors to label these products as “mechanically tenderized,” USDA will also require processors to include validated cooking instructions which, if followed, will ensure that any harmful pathogens in these products are destroyed. The question, then, for industry will be whether cooking mechanically tenderized steaks to the higher temperatures needed to kill foodborne pathogens will prevent them in most cases from being served “rare” or even “medium rare.”

To justify its new rules, USDA has cited a number of recent outbreaks caused by mechanically tenderized steaks. According to USDA, since the year 2000, there have been a total of six E. coli O157:H7 foodborne illness outbreaks attributable to mechanically tenderized steaks served in restaurants and consumer homes. These six outbreaks, spanning 13 years, have included a total of 176 confirmed E. coli O157:H7 cases that resulted in 32 hospitalizations and 4 cases of HUS (acute renal failure).

While you can decide for yourself whether such a substantial change in the labeling of steak products is warranted by the fewer than 15 cases reported annually since 2000, what we do know is that the labeling rules are changing fast, and serving mechanically-tenderized medium rare steaks in restaurants may no longer be a legal option. Time (and temperature), of course, will tell. Ultimately, this is because whether the term “medium rare” survives will depend upon the validation studies governing any new labeling. USDA’s rules will require validated instructions to include, at a minimum: (1) the method of cooking; (2) a minimum internal temperature validated to ensure that potential pathogens are destroyed throughout the product; (3) whether the product needs to be held for a specified time at that temperature before consumption; and (4) an instruction that the internal temperature should be measured by the use of a thermometer.

In turn, processors will need to demonstrate to USDA that the instructions are also “scientifically supported,” meaning they must demonstrate that: (a) the cooking instructions can repeatedly achieve the desired minimum internal temperature and, if applicable, rest time; and (b) the minimum internal time and, if applicable, rest time achieved by the instructions will ensure that the product is fully cooked to a level designed to destroy any potential pathogens throughout the product. On the other side of the coin, even if processors could properly validate their cooking instructions, it may be that we see some major restaurant chains shift away from using these products altogether.

Indeed, once the new labeling requirements go into effect, then restaurants will have a difficult decision to make: comply with the labeling instructions, or ignore them?Responsible restaurant chains will, of course, determine that they need to comply with the instructional labels. This is because the instructions, themselves, anticipate (or, at least warn) that the product at issue could possibly contain pathogens and thus must be cooked to a predetermined temperature in order to render that product safe for consumption. If those instructions are ignored, however, and a customer becomes sick (or, even dies, as a result), that company could be exposed to significant punitive damages for disregarding a known risk. Thus, the only responsible course will be to either: (1) refine internal policy to ensure that all such products are cooked to the recommended temperatures; or (2) to purchase steaks that are not mechanically or needle tenderized. There really will be no other options.

So, the most likely longer term result, in my opinion, may be that the restaurant industry will begin to move away from needle or mechanically-tenderized products, unless and until those products can be subjected to processing interventions (like irradiation) that will allow the end users to prepare and then serve them somewhere south of well-done.

So, if you like selling or serving (or, I suppose, eating) steaks that can be cooked medium rare, you may want to watch these new rules closely. In in the end, “medium rare” may become much more rare you think.

About The Author

Shawn K. Stevens is a food safety lawyer and founding member of Food Industry Counsel, LLC, the only law firm in the world that represents the food industry exclusively. Stevens works throughout the country and abroad with food industry clients (including the world’s largest food processors, national restaurant chains, and food distributors and grocers), helping them protect their brand by proactively eliminating their food safety risk, complying with complex FDA and USDA food safety regulations, managing recall response efforts, and defending high-profile foodborne illness claims. Stevens speaks regularly to national and international audiences on a wide variety of emerging scientific, regulatory and legal food safety trends, authors dedicated columns for Meatingplace and The National Provisoner, and is quoted regularly by national media publications such as TIMEMagazine, the New York Post, and Corporate Counsel Magazine.

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Horsfall began his career in California agriculture with the California Table Grape Commission, Fresno, CA, where he served most recently as Vice President, International Marketing. At the CTGC, Horsfall oversaw an annual $3.5 million export promotion program. During his tenure grape exports increased over 600% in 14 years. He has served on several industry boards and committees. He served as chairman of the United States Agricultural Export Development Council (USAEDC), was a member of the Agricultural Trade Advisory Committee (ATAC) for fruits and vegetables and is a past chairman of the Produce Marketing Association’s International Trade Conference.

Horsfall has a MA in international relations from California State University/Fresno and a BA in communications from Brigham Young University in Provo, Utah.

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Robach started out his career with Monsanto Company. Prior to joining Cargill, Robach headed up technical services for Conti Group’s meat and poultry businesses. He is a graduate of Michigan State University and Virginia Tech. He is past President for Safe Supply of Affordable Food Everywhere (SSAFE), Chairman of the Board of Directors of the Global Food Safety Initiative (GFSI), a member of the Scientific and Regulatory Affairs Council Executive Committee for the Grocery Manufacturers Association, and a member of the U.S. Poultry and Egg Association’s Research Advisory Committee. He is also a member of the American Meat Institute, the National Turkey Federation, the International Association of Food Protection, the Institute of Food Technologists, and the American Society for Microbiology. Robach has worked with the World Organization of Animal Health (OIE) and the Food and Agriculture Organization (FAO) on harmonized animal health andfood safety standards. He has worked closely with the USDA and FDA regarding food safety policy, HACCP, and regulatory reform based on science. From 1995 through 2000, Robach was a member of the National Advisory Committee for Microbiological Criteria in Foods.

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Palmer A. Orlandi, Jr., Ph.D., senior science officer and research director in FDA’s Office of Foods and Veterinary Medicine, was recently promoted to the rank of Rear Admiral and the U.S. Assistant Surgeon General. Orlandi joined FDA 20 years ago, beginning his work at a research lab for CFSAN. It was there that he developed rapid and molecular detection methods for Cyclospora and Cryptosporidia and the Microsporidia (emerging food-and waterborne protozoan parasites). In 2008 he became the science coordinator in the Division of Field Science in FDA’s Office of Regulatory Affairs (ORA) where he oversaw collaborative analytical methods programs for ORA and the Food Emergency Response Network. In 2012 Orlandi took on the role of senior science advisor to the chief scientist officer at the Office of Food and Veterinary Medicine. He played an active role in integrating science and research efforts across the agency’s foods program, and working to align research and lab programs to regulatory field lab needs.

Darin Detwiler, M.A.Ed., DLP is the director: regulatory affairs of food and food industry, assistant teaching professor in the College of Professional Studies at Northeastern University. Prior to this role, he was the senior policy coordinator for food safety at STOP Foodborne Illness, (a national non-profit public health organization dedicated to the prevention of illness and death from foodborne illness.). Detwiler has spent two decades working in the support and reform of food policy. Four different secretaries of agriculture have recognized Detwiler for his efforts in the USDA’s Pathogen Reduction Program. From 2004–2007, he served on the USDA’s National Advisory Committee on Meat and Poultry Inspection. He is also an FDA-certified food science educator whose work can be found on television, radio and in industry journals and newspapers, including the New York Times. Detwiler is a former high school teacher and adjunct professor of science and history, as well a navy veteran.

Melanie Neumann of Neumann Risk Services, LLC,

Melanie Neumann, J.D., M.S. is the president and global food safety attorney of Neumann Risk Services, LLC (NRS). NRS provides regulatory, business and brand counsel to help the food and beverage industry manage these various risks. NRS is a holistic food safety risk management firm where food law, food safety, food science and brand reputation converge. With more than 18 years of experience advising food and beverage companies, Neumann leverages her years as an attorney along with her master’s degree in food safety to help clients understand the risks relating to food laws and regulatory compliance from compliance, operational and brand perspectives. This involves working with companies to interact with regulators in response to investigation findings, enforcement actions and recalls, FSMA compliance and other FDA and USDA regulations. Neumann also works with companies to identify risk-based strategies to manage supply chain risks through an enterprise risk management approach and helps clients tackle emerging food safety risks and regulatory changes in both the United States and international markets.

Neumann is active in the Global Food Safety Initiative (GFSI), is a technical working group member of the GFSI Global Markets Program Strategy, as well as a member of the Scientific Organization Committee of The Sackler Institute of Nutrition Science of the New York Academy of Sciences. She is an avid runner, marathoner, triathlete and four-time Ironman finisher.

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As an owner and operator of her own organic bakery, to Manager of Public Health Promotions and a Registered Sanitarian at the Columbus Public Health Department, to her role as Senior Manager of Food Safety & Quality at The Kroger Co., Gina Nicholson-Kramer has spread her knowledge and innovative approach of food safety to organizations small and large.

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John Butts received his Ph.D. in Food Science from Purdue University in 1974 & joined Land O’ Frost 1974. He is a member of the Board of Directors of the American Meat Institute and is an active member of the Scientific Affairs Committee (SAC) for over 35 years. He serves on the Meat Inspection Committee, Facility Design Task Force, AMIF Research Advisory and is an AMI Listeria Intervention and Control Workshop team member, co-author and instructor. Butts received the 2005 Food Safety Leadership Award, NSF International. Outstanding Food Science Award, Inaugural class recipient, Purdue University, 2006 Food Safety Magazine Distinguished Service 2008 Meat Processing Award by the AMSA. 2009 AMIF Scientific Achievement Award and the 2013 Certificate of Distinction from Purdue Ag Alumni.

Shawn K. Stevens is a food safety lawyer and founding member of Food Industry Counsel, LLC, the only law firm in the world that represents the food industry exclusively. Stevens works throughout the country and abroad with food industry clients (including the world’s largest food processors, national restaurant chains, and food distributors and grocers), helping them protect their brand by proactively eliminating their food safety risk, complying with complex FDA and USDA food safety regulations, managing recall response efforts, and defending high-profile foodborne illness claims. Stevens speaks regularly to national and international audiences on a wide variety of emerging scientific, regulatory and legal food safety trends, authors dedicated columns for Meatingplace and The National Provisoner, and is quoted regularly by national media publications such as TIME Magazine, the New York Post, and Corporate Counsel Magazine.

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